Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (SITACABG NonDM)
Coronary Artery Disease
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Non diabetic hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- No previous history of diabetes
- No previous history of hyperglycemia
Exclusion Criteria:
- Patients with hyperglycemia (blood glucose > 125 mg/dL); or glycated hemoglobin (HbA1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
- Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR < 30 mL/min) or clinically significant hepatic failure
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
- Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
- Patients with clinically relevant pancreatic or gallbladder disease
- Treatment with oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the scope, and consequences of the study
- Female subjects who are pregnant or breast feeding at time of enrollment into the study
Sites / Locations
- Grady Health System
- Emory University Hospital - Midtown
- Emory University Hospital
- Emory Saint Joseph's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sitagliptin
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.